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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2015/10/006320 | Registry Identifier | CTRI |
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Discontinuation of product development
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The purpose of this study is to evaluate the efficacy and safety of Systane® Balance following 90 days of QID (4 times/day) dosing among Indian subjects with dry eye.
This study was conducted in India.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systane Balance | Experimental | Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propylene Glycol 0.6% eye drops | Other |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Corneal Staining Total Score | The type (severity) of staining was assessed for each of the 5 regions of the cornea (central, inferior, temporal, superior, and nasal) and graded on a 4-point scale, where 0 = Normal (No staining) and 3 = Severe (Numerous coalescent macropunctate areas and/or patches). The scores of the 5 regions were summed to obtain a corneal staining total score for each eye (minimum 0, maximum 15). | Baseline (Day 0), Day 45, Day 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alcon Research, Ltd | Alcon Research | Study Director |
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Participants were enrolled from 4 study sites located in India.
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| ID | Title | Description |
|---|---|---|
| FG000 | Systane Balance | Propylene Glycol 0.6% eye drops, 1 drop QID (4 times/day) (with the last dose of each day at bedtime) in each eye for 90 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Systane Balance | Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Corneal Staining Total Score | The type (severity) of staining was assessed for each of the 5 regions of the cornea (central, inferior, temporal, superior, and nasal) and graded on a 4-point scale, where 0 = Normal (No staining) and 3 = Severe (Numerous coalescent macropunctate areas and/or patches). The scores of the 5 regions were summed to obtain a corneal staining total score for each eye (minimum 0, maximum 15). | Analysis includes all participants with data present. Analysis was based on the eye with the higher corneal staining total score at screening or the right eye when both eyes have same corneal staining total score at screening, as observed. | Posted | Mean | Full Range | units on a scale | Baseline (Day 0), Day 45, Day 90 |
|
Adverse events were collected for the duration of participation, an average of 90 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Systane Balance | Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director Med Affairs | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D019946 | Propylene Glycol |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
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| D019999 |
| Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |